March 11, 2024 — Laekna (2105.HK) announced that the company has submitted the Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for LAE102, an internally discovered monoclonal antibody against ActRIIA, for the treatment of adult patients with obesity or metabolic diseases. 

According to the regulations, the FDA will review and respond to an IND sponsor within 30 calendar days upon receiving a complete IND application. In February 2024, the IND of LAE102 for obesity has been accepted by the CDE.

LAE102 is a monoclonal antibody against ActRIIA, a receptor that plays an important role in muscle regeneration and lipid metabolism.  In the pre-clinical models, LAE102 has been shown to increase lean mass and decrease fat mass. In combination with GLP1R agonist, LAE102 can further reduce fat mass and dramatically attenuates lean mass loss induced by GLP1R agonist.  This makes LAE102 a drug candidate for achieving quality weight control through reducing fat while keeping muscle mass.

"We’ve submitted IND applications for LAE102 to the CDE and FDA for obesity or metabolic diseases, demonstrating the know-how and commitment of Laekna in pursuit of novel drugs for the indications”, said Dr. Chris Lu, Chief Executive Officer of Laekna, “We will work closely with the regulatory authorities to complete the application and  look forward to bringing the precision therapy to obesity or metabolic patients”.

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About Laekna

Founded in 2016, Laekna is a science-driven, clinical-stage biotechnology company committed to bringing novel therapies to cancer and liver fibrosis patients worldwide.

As of June 30, 2023, Laekna has initiated six clinical trials for afuresertib (LAE002), LAE001 and LAE005 to address unmet medical needs in cancers, such as ovarian cancer, breast cancer and prostate cancer. Among the six clinical trials, three are multi-regional clinical trials (MRCTs), including one pivotal trial.

Laekna’s internal drug discovery platform has discovered 12 drug candidates. LAE102 is our first internally discovered antibody which has obtained IND approvals from the FDA and CDE. Its potential indications include muscle regeneration, obesity, and cancer.

Laekna, Inc. was listed on the Main Board of The Stock Exchange of Hong Kong Limited (the “Hong Kong Stock Exchange”) on June 29, 2023. The stock code is 2105.HK.

For more information, please visit: https://www.laekna.com/

or https://www.linkedin.com/company/74110713/

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